NCT04042974

Brief Summary

To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

July 31, 2019

Last Update Submit

July 31, 2019

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

    an expected average of 10 minutes

Secondary Outcomes (2)

  • Intensity of pain

    30 minutes after the procedure

  • Operative time

    an expected average 10 minutes

Study Arms (2)

dinoprostone

EXPERIMENTAL

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Drug: vaginal dinoprostone

placebo

PLACEBO COMPARATOR

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Drug: placebo

Interventions

vaginal dinoprostoneDRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

dinoprostone
placeboDRUG

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

placebo

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

You may not qualify if:

  • women with suspected pregnancy
  • heavy vaginal bleeding
  • recent pelvic infection
  • those known to have hypersensitivity or contraindication to dinoprostone
  • those who received analgesics prior to OH
  • a concomitant neurologic disease that could affect the correct evaluation of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • AHMED SAMY, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

+201100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

August 10, 2019

Primary Completion

November 10, 2019

Study Completion

November 20, 2019

Last Updated

August 2, 2019

Record last verified: 2019-07